2015 WATCHMAN Left Atrial Appendage Closure Device (The WATCHMAN Device) Coding Guide- Structural Heart Contents

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1 2015 WATCHMAN Left Atrial Appendage Closure Device (The WATCHMAN Device) Coding Guide- Structural Heart Contents Reimbursement Overview... 2 Physician Reimbursement... 2 Physician Coding... 2 WATCHMAN Procedure... 2 Echocardiography... 3 Physician Coverage... 4 Physician Payment... 4 Physician Crosswalk Analogy Hospital Reimbursement... 6 Hospital Coding... 6 Hospital Payment... 6 Payer Communications... 7 Prior Authorization Resources... 8 Medicare... 8 Medicare Advantage and Other Private Payers... 8 Appealing Denials... 9 Coding & Reimbursement Support... 10

2 Reimbursement Overview The table below provides an overview of coding, coverage and payment for the WATCHMAN Left Atrial Appendage (LAA) Closure Therapy across sites-of-service and by payer. Medicare Private Payer Coding Coverage Payment Coverage Payment Hospital Inpatient ICD-9 procedure code Varies by locality Most common assignment are DRG 251 or 250 Varies by Payer policy for LAA Closure procedures Dependent on payer contract Hospital Outpatient CPT III code 0281T Designated as Inpatient Only NA Likely Not Allowed NA Physician CPT III code 0281T Refer to contractor policy on Category III CPT codes At local contractor s discretion; Requires add l documentation Refer to payer policy on Category III CPT codes & LAA Closure procedures At payer s discretion; Requires add l documentation Physician Reimbursement Physician Coding WATCHMAN Procedure For the WATCHMAN LAA Closure procedure, physicians will use the Category III CPT Code 0281T to report implantation of the WATCHMAN device. This code became effective on January 1, 2012 and is used specifically to allow Medicare and private payers to more appropriately determine utilization and capture resources associated with the WATCHMAN LAA Closure procedure. Category III CPT Code T Description Percutaneous transcatheter closure of the left atrial appendage with implant, including fluoroscopy, transseptal puncture, catheter placement(s) left atrial angiography, left atrial appendage angiography, radiological supervision and interpretation Page 2 of 11

3 Providers should not use the unlisted codes 93799, unlisted cardiovascular service or procedure, or 33999, unlisted cardiac surgery procedure as the Category III CPT Code 0281T is reserved specifically for reporting the WATCHMAN LAA Closure procedure. The Category III CPT Code 0281T is designated with a status indicator of C which indicates that this service must be provided in the hospital inpatient site of service. Some private payers may allow this procedure to be performed in the hospital outpatient setting; verify and confirm with your payer in advance. Echocardiography Transesophageal echocardiography (TEE) plays a critical role in visualization and assisting with appropriate candidacy for the WATCHMAN Device. Based on our Directions for Use, the WATCHMAN procedure involves use of TEE imaging as follows: Baseline TEE: This TEE is usually performed prior to the implant procedure to determine if the patient is a suitable candidate for the WATCHMAN Device. (CPT code: 93312) Intraoperative TEE: This TEE is performed during the WATCHMAN implant procedure and provides guided imaging to facilitate device placement (CPT code: 93355). Follow up TEE: This TEE is performed usually 45 days after the WATCHMAN implant to ensure appropriate endothelization/healing of the left atrial appendage (LAA). Based on physician assessment, additional follow up TEE may be recommended at 6 months and one year post implant to assess appropriate closure of the LAA (CPT code: 93312). The baseline and follow up TEE to support the WATCHMAN procedure may be reported with the following code as appropriate: 93312: Echocardiography, transesophageal, real-time with image documentation (2D) (with or without M-mode recording); including probe placement, image acquisition, interpretation and report For the intraoperative TEE, the American Society of Echocardiography (ASE) has recently received approval for a new interventional transesophageal echocardiography code for use beginning in This will also apply to WATCHMAN implants utilizing intraoperative TEE. This code, is intended to be used to report TEE services during an interventional procedure for real-time guidance, image acquisition, documentation and interpretation during transcatheter intracardiac procedures. The work value for this code is 4.66 with total RVUs of 6.40 for CY2015. The complete descriptor for code is: 93355: Echocardiography, transesophageal (tee) for guidance of a transcatheter intracardiac or great vessel(s) structural intervention(s) (e.g.,tavr, transcathether pulmonary valve replacement, mitral valve repair, paravalvular regurgitation repair, left atrial appendage occlusion/closure, ventricular septal defect closure) (peri-and intra-procedural), real-time image acquisition and documentation, guidance with quantitative measurements, probe manipulation, Page 3 of 11

4 interpretation, and report, including diagnostic transesophageal echocardiography and, when performed, administration of ultrasound contrast, doppler, color flow, and 3D. Code is reported once per intervention and only by an individual who is not performing the interventional procedure (i.e., WATCHMAN implant). A corrective coding initiative (CCI) edit exists with the code pairs 0281T and which indicate that these code pairs should not be reported together. This CCI edit will accept a modifier to provide additional clarification of why these code pairs are reported together. Physician Coverage Category III CPT Codes are often used to track utilization of new and emerging technologies, and are often assigned prior to FDA approval. As a result, most Medicare administrative contractors (MACs) and private payers treat Category III codes as investigational and experimental and default to non-coverage of procedures reported with these codes. Payers may consider coverage on a case-by-case basis. The physician will need to provide justification for medical necessity and appropriateness based upon the patient s particular circumstance and should always seek prior authorizations for WATCHMAN implants. Traditional Medicare does not offer prior authorization and providers would need to work with local contractors in appealing denials. Resources to support this process are provided in the Payer Communications and Prior Authorization sections of this document. Physician Payment Category III CPT codes do not have assigned Relative Value Units (RVUs) for calculation of physician payment. When communicating with payers, physicians will need to select an existing procedure with similar resource use to serve as a reference for mapping appropriate professional payment. (Refer to the Physician Procedure Crosswalk Analogy.) Payment will be at the discretion of payers and are often carrier priced. Physicians who have RVU-based compensation plans should also talk with their employer or practice manager to establish a value for the WATCHMAN implant procedure, in order to be credited appropriately for their work. Refer to physician crosswalk table. Page 4 of 11

5 Physician Crosswalk Analogy Experienced WATCHMAN Device implanters and professional societies have identified the following procedures as comparable to a WATCHMAN implant in terms of resource utilization. Clinician opinions may vary. Physicians are encouraged to crosswalk to a procedure that they feel is most comparable. RVUs associated with the comparable procedure are reported on the claim. CPT code and description 2015 Physician Fee Schedule Value* 0281T Percutaneous left atrial appendage closure with implant (LAA) Total RVU: 0 (Category III CPT codes do not have any relative value units.) Paid at individual payer discretion Percutaneous transcatheter closure of congenital interatrial communication with implant (PFO or ASD) AND Left heart catheterization by transseptal puncture through intact septum or by transapical puncture Total 2015 RVU: Total Payment: $1,227 Procedure Work RVU: Transitional PE RVU: 6.47 Malpractice RVU: 3.86 Nat Avg. Payment: $1,012 AND Procedure Work RVU: 3.73 Transitional PE RVU: 1.47 Malpractice RVU: 0.83 Nat Avg. Payment: $ Percutaneous transcatheter closure of a congenital ventricular septal defect with implant (VSD) Total 2015 RVU: Total Payment: $1,383 Work RVU: Transitional PE RVU: 8.61 Malpractice RVU: 5.68 Nat Avg. Payment: $1,378 Sedation type General anesthesia Conscious sedation General anesthesia Imaging Technique Use real-time transesophageal echocardiography (TEE) and fluoroscopy to facilitate device placement Use real-time intracardiac echocardiography (ICE) and fluoroscopy to facilitate device placement Use real-time transesophageal echocardiography (TEE) and fluoroscopy to facilitate device placement Catheterization Right heart catheterization Right heart catheterization Femoral vein and artery approach Access technique Transseptal puncture Use congenital defect Typically, femoral artery retrograde to access left ventricle. May include transseptal puncture. Procedural steps Access left atrial Access defect Access defect appendage Size defect and choose Size defect and Size opening and appropriate device size choose appropriate choose appropriate Position in defect device size device size Reposition if necessary Position in defect Position in LAA Deploy device to close Reposition if Reposition if defect necessary necessary Deploy device to Deploy device to close off LAA close defect *As a result of the recent SGR passed earlier this year, the current conversion factor (CF) of $ remains effective until December 31, 2014 with a zero percent update beginning January 1 through March 31, The CY2015 PFS CF for January 1, 2015 through March 31, 2015 is $ which is reflected in the physician payment rates noted above. Unless Congress acts, rates would be cut by 21% beginning April 1, Page 5 of 11

6 Hospital Reimbursement Hospital Coding The ICD-9-CM procedure code used to report a WATCHMAN implant in the hospital inpatient is provided below. ICD-9 Procedure code 2 Procedure Description Insertion of a left atrial appendage device, transseptal catheter technique Medicare has determined that the WATCHMAN LAA Closure procedure must be performed in the inpatient hospital site of service. The Category III CPT Code 0281T is designated with a status indicator of C which limits this in the inpatient hospital only and it is not an approved procedure in the outpatient hospital. The Medicare inpatient-only list of codes is found in Addendum E. Medicare s Inpatient-Only list at 42 C.F.R (n) defines services that support an inpatient admission and Part A payment as appropriate, regardless of the expected length of stay. As an inpatient-only procedure, WATCHMAN device implant procedures are not restricted by Medicare s two midnight rule. Additional information can be found by clicking the link. Some private payers may allow this procedure to be performed in the hospital outpatient setting, but coverage and payment will vary so it is important to verify and confirm with your payer. C-codes The WATCHMAN procedure is designated by Medicare as an inpatient only procedure. Therefore, no C- code is assigned to the WATCHMAN Device. C-codes are reported for device-intensive procedures performed in the outpatient hospital site of service. Hospital Payment Inpatient services are assigned to medical severity diagnosis related groups (MS-DRGs) for payment. Based on the inpatient ICD-9 code (37.90) and a diagnosis of atrial fibrillation, WATCHMAN procedures would typically map to MS-DRG 250 or 251. MS-DRG MS-DRG Description FY2015 National Average Base Payment* MS-DRG 250 Percutaneous Cardiovascular Procedure without $ 17,529 Coronary Artery Stent with MCC MS-DRG 251 Percutaneous Cardiovascular Procedure without $ 11,965 Coronary Artery Stent without MCC * Centers for Medicare and Medicaid Services. Medicare Program: FY2015 Hospital Inpatient Prospective Payment System, Final Rule; August 22, 2014 Page 6 of 11

7 Hospital Coverage Medicare may not have payment edits set up to explicitly link non-coverage of inpatient procedure code Regardless, it is always the responsibility of the provider to adhere to local coverage guidance and private payer policies when applicable. Because Category III code 0281T is explicitly non-covered by most Medicare contractors, hospitals should anticipate denials for left atrial appendage closure procedures. Hospitals should work with local contractors to appeal denials in supporting the medical necessity of the WATCHMAN implant. Payer Communications Category III CPT Codes and Implications for WATCHMAN LAA Closure Procedures Upon FDA approval, WATCHMAN implant claims reported with Category III code 0281T will likely be denied by local Medicare contractors in the absence of a local or national coverage decision (LCD or NCD). It is important that providers work locally with the Medicare contractors to appeal these denials based on medical necessity. Appeals and support materials are referenced throughout this guide. In the interim, Boston Scientific is working with Medicare to minimize the coverage gap to ensure appropriate access for your patients that qualify for this important therapy. For private payers, coverage will be based on their policies for Left Atrial Appendage Closure procedures. We highly encourage physicians and hospital providers to check for existing policies in advance of performing WATCHMAN implants. In addition, physician and hospital providers should always seek prior authorization for individual coverage consideration of WATCHMAN LAA Closure based on your patients medical circumstances. Prior authorization and peer-to-peer reviews are recommended tools for assisting with patient access in light of non-coverage policies. Please refer to the Prior-Authorization section to assist with best practices in securing approval for WATCHMAN LAA Closure procedures. FDA Approval The WATCHMAN LAA Closure device has received FDA approval so it should not be treated as an investigational device. Please go to to access FDA approval letter to include in your prior authorization and appeals requests. The WATCHMAN Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who: Are at increased risk for stroke and systemic embolism based on CHADS 2 or CHA 2 DS 2 - VASc 1 scores and are recommended for anticoagulation therapy; Are deemed by their physicians to be suitable for warfarin; and 1 January CT, Wann LS, Alpert JS, et. al., 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society, Circulation, 2014; 130: e199-e267. Page 7 of 11

8 Have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin. Prior Authorization Resources Medicare Medicare does not perform or offer prior authorizations for the WATCHMAN LAA Closure procedure. Medicare Advantage and Other Private Payers Prior authorization is a process established by commercial insurance plans that allows a physician to submit a treatment plan prior to surgery. The insurer reviews the treatment plan as well as the patient s insurance benefits and medical policy to determine if the treatment is covered and the applicable patient responsibility (e.g., coinsurance and/or copay, deductibles, and out-of-pocket amounts). As prior authorization processes vary by insurer, it is important to contact insurance plans and follow their specific requirements. Prior authorization requests typically include the following elements: Patient information name, date of birth, policy number Details of the patient s medical history Description of the patient s current condition and treatment plan Letter of medical necessity (LOMN) documenting the patient s medical need Proposed procedure(s), medical device implanted and rationale for treatment Proposed location of service and dates planned Summary of the clinical evidence supporting the treatment plan including comorbidities and copies of published literature supporting the safety and effectiveness. Recent peer review literature regarding the WATCMAN include: o Holmes, DR, Reddy VY, Doshi, SK et al. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomized non-inferiority trial (PROTECT AF). o Lancet. 2009; 374: Reddy, VY, Doshi, SK, Sievert, H et al. Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-year followup of the PROTECT AF (WATCHMAN left atrial appendage system for embolic protection in patients with atrial fibrillation) Trial. Circulation. 2013; 127: o Holmes DR, Kar S, Price M, Whisenant B, Sievert H, Doshi S, Huber K, Reddy V. Prospective randomized evaluation of the Watchman left atrial appendage Device in patients with atrial fibrillation versus long-term warfarin therapy; the PREVAIL trial. Journal of the American College of Cardiology, Vol. 4, No. 1, 2014, o Reddy VY, Sievert H, Halperin J, et al. Percutaneous Left Atrial Appendage Closure vs Warfarin for Atrial Fibrillation: A randomized clinical trial. JAMA. 2014;312(19): Description of the technology and rationale for its use in the patient s surgery Page 8 of 11

9 Copy of the FDA approval letter (available through your Boston Scientific Sales Representative or by calling CARDIAC, and ask for the reimbursement support line) Please go to to access a sample prior authorization template. Appealing Denials Medicare contractors and commercial payers have documented appeals processes for reconsidering denials. Since Medicare does not perform prior authorizations, providers would proceed with performing the procedure (based on medical necessity), submit the claim to the MAC, and then wait to receive a payment or denial. If the MAC denies the claim, Medicare has a defined appeals process with up to five levels of appeals. Additional information and an overview of this process are found by clicking here. The first level of Medicare appeal is known as Redetermination where providers have 120 days from the date of the receipt of the initial claim decision to appeal. Medicare provides a specific form (Form CMS-20027) to standardize the information needed to request initial redeterminations. Appeals information regarding private payer processes are found in the plan s provider manual and/or website or by contacting the insurer directly. If you need to appeal a prior authorization decision, physician providers should request a peer-to-peer review with a like specialty (i.e. Electrophysiology or Interventional Cardiology) to best communicate the WATCHMAN LAA closure procedure and patient treatment pathway. When speaking with the plan s Medical Director, focus on the benefits of the WATCHMAN LAAC technology and the medical necessity based upon the individual patient s symptoms, diagnosis and comorbidities. Clinicians may also request a third party like peer-to-peer review of the claim, ideally with a board-certified Electrophysiologist who understands the therapy. Appeal letters typically include the following elements for both Medicare and private payers: Provide the rationale for filing an appeal (denial of coverage, medical necessity, etc.) Date of denial/denial letter Reference the denial reason and associated denial code, if applicable Detail the patient s diagnosis and course of treatment including adverse outcomes or lack of improvement from prior therapies. Describe the surgery in detail Describe any medical device and its benefits as they relate to the patient s condition. Emphasize the advantages of the medical device as compared to another medical device or approach State the rationale and benefits of the technology and how its use can be expected to produce a superior clinical outcome for the patient Discuss personal experiences and outcomes of surgical cases using the medical device Reference peer review literature to support the clinical determination regarding medical necessity. Recent peer review literature regarding the WATCHMAN device include: o Holmes, DR, Reddy VY, Doshi, SK et al. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients Page 9 of 11

10 with atrial fibrillation: a randomized non-inferiority trial (PROTECT AF). Lancet. 2009; 374: o Reddy, VY, Doshi, SK, Sievert, H et al. Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-year followup of the PROTECT AF (WATCHMAN left atrial appendage system for embolic protection in patients with atrial fibrillation) Trial. Circulation. 2013; 127: o Holmes DR, Kar S, Price M, Whisenant B, Sievert H, Doshi S, Huber K, Reddy V. Prospective randomized evaluation of the Watchman left atrial appendage Device in patients with atrial fibrillation versus long-term warfarin therapy; the PREVAIL trial. Journal of the American College of Cardiology, Vol. 4, No. 1, 2014, o Reddy VY, Sievert H, Halperin J, et al. Percutaneous Left Atrial Appendage Closure vs Warfarin for Atrial Fibrillation: A randomized clinical trial. JAMA. 2014;312(19): Provide a contact name and phone number as well as the willingness to answer questions or provide additional information Request a specific timeframe for a response Please go to the WATCHMAN device website: to access a sample appeals template that you can customize specific to the medical appropriateness of WATCHMAN device for your patients. Coding & Reimbursement Support Boston Scientific is dedicated to providing physicians, allied health professionals and hospitals with world-class programs and services to help advance the standard of patient care and appropriate access to life-enhancing technologies. Call CARDIAC ( ) and ask for WATCHMAN Reimbursement. All WATCHMAN reimbursement resources are easily accessed at Important Information Health economics and reimbursement information provided by Boston Scientific Corporation is gathered from third-party sources and is subject to change without notice as a result of complex and frequently changing laws, regulations, rules and policies. This information is provided for illustrative purposes only and does not constitute reimbursement or legal advice. Boston Scientific encourages providers to submit accurate and appropriate claims for services. It is always the provider's responsibility to determine medical necessity, the proper site for delivery of any services and to submit appropriate codes, charges, and modifiers for services that are rendered. Boston Scientific recommends that you consult with your payers, reimbursement specialists and/or legal counsel regarding coding, coverage and reimbursement matters. Boston Scientific does not promote the use of its products outside their FDA-approved label. Payer policies will vary and should be verified prior to treatment for limitations on diagnosis, coding or site of service requirements. The coding options listed within this guide are commonly used codes and are not Page 10 of 11

11 intended to be an all-inclusive list. We recommend consulting your relevant manuals for appropriate coding options. References 1 CPT copyright 2014 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Restrictions Apply to Government Use. Fee schedules, relative value units, conversion factors, and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. 2 American Medical Association: 2014 ICD-9-CM for Hospitals, Volumes 1, 2 and 3, Professional Edition, Chicago, IL. WATCHMAN is a registered or unregistered trademark of Boston Scientific Corporation. All other trademarks are the property of their respective owners. Page 11 of 11

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